Date: 2011-01-11
Type of information:
phase: 2
Announcement: initiation of a trial
Company: Sandoz (Switzerland)
Product: biosimilar rituximab
Action mechanism: Mabthera® / Rituxan® is a monoclonal antibody directed against the CD20 protein found on the surface of B-cells.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details:
Latest
news: * On January 10, 2011, Sandoz has announced that it has begun a phase II clinical trial in patients for biosimilar rituximab (Roche’s Rituxan® / Mabthera®), a leading monoclonal antibody indicated in conditions including non-Hodgkin’s lymphoma and rheumatoid arthritis.The phase II study in patients suffering from rheumatoid arthritis aims to demonstrate bioequivalence to the reference product, and will collect data on pharmacokinetics and pharmacodynamics as well as efficacy and safety data.Over the past few years Sandoz has developed a robust, high-yield and large-scale process for the production of biosimilar rituximab in its own facilities in Schaftenau, Austria. To ensure biosimilarity with the reference product, a comprehensive physico-chemical and functional analysis of the product was conducted using modern bioanalytic techniques, followed by further studies. The data suggest that Sandoz’s biosimilar rituximab is highly similar to the reference product, justifying initiation of clinical studies in patients.
